Friday Feedback: Is Consent After the Fact OK?

At the American College of Cardiology meeting earlier this week, the HEAT PPCI study's use of post-treatment consent caused a stir. The protocol treated patients with approved drugs used according to label indications and was approved by three IRB boards in the U.K., where the trial was conducted. Still, the process raised ethical issues among attendees.

We reached out to physicans and healthcare professionals by email and asked them to respond to the following question:

What are your thoughts about whether post-treatment consent should be allowed in clinical trials, and what considerations should clinicians take into account?

David R. Holmes, MD: "Different countries and societies vary on those principles used to protect patients. In some countries all patients are entered into national registries which provide a tremendous resource for scientific data used to optimize clinical practice. In other countries or, for example, in states like Minnesota, patients can refuse to have any data which is completely de-identified used for research."

Josephine Johnston, LLB, MBHL: "The need for informed consent in comparative effectiveness studies of this kind is being actively debated in the U.S. right now."

It's Clear Cut

Stuart Finder, PhD: "Post-experiment consent obfuscates these distinctions, and in so doing, creates a setup not only for misunderstanding, but potential coercion and abuse."

Greg Koski, MD, PhD: "There is no such thing as retrospective, 'post-experiment' consent for participation in research. Informed consent is necessarily prospective. An individual can only make an informed decision regarding participation before entering a study."

Ruth Macklin, PhD: "Obtaining informed consent before enrolling an individual in biomedical research has been a bedrock ethical requirement for more than half a century. Internationally, the requirement goes back to the 1947 Nuremberg Code, following the gruesome experiments by the Nazis. Even more relevant is the Declaration of Helsinki, a living document whose latest revision was issued by the World Medical Association in October, 2013: '... no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.'

"When two approved treatments commonly used in medical practice are compared in a clinical trial, some physicians and even some ethicists argue that no informed consent is needed, before or after the study. This erosion of informed consent is a return to the dark ages of medical research, when doctors experimented on patients without their knowledge or consent."

HEAT PPCI a Special Case?

Holmes: "The HEAT PPCI study was approved by three institutional review boards in the U.K. and also approved by patient representatives. The results will be important for several reasons. While such a trial design may not prove acceptable to some countries, the results are important, and the study was performed with input from the responsible agencies."

Macklin: "The defense of 'post-experiment consent' by researchers in the HEAT PPCI trial is ethically flawed. What could 'post-experiment consent' possibly mean? What would people be consenting to after their participation in research? The only possibility is the use of their data. This exemplifies an even more dangerous trend in research of this type, known as 'comparative effectiveness research.'"

Johnston: "While the HEAT PPCI study would likely not be approved under current federal human subject regulations, some medical ethicists believe that the promise of learning healthcare systems can only be realized by relaxing informed consent requirements in situations such as these. Where there is genuine uncertainty about which treatment is most effective, and where both treatments are approved and indicated for the patient, the question becomes not just 'should consent be delayed' (as it was in the HEAT PPCI study), but 'is consent needed at all.'"

Physician Versus Researcher

Finder: "One of the most challenging aspects of clinical research is keeping the lines of responsibility straight. As a clinician, a physician's primary responsibility is to the welfare and well-being of the individual immediately in front of him or her, i.e., the patient. As a researcher, on the other hand, the physician's primary responsibility is to the generation of good data that may be used to answer the scientific question at hand; as such, the individual immediately in front of him or her, i.e., the human subject, is the means to an end.

"Patients expect that their needs are primary, and that expectation should be upheld by their care providers. Patients who become human subjects need to be educated, and often reminded throughout the course of a study, that their status is different -- even in the midst of receiving direct care.

"On both sides of the equation, in other words, the differences in responsibilities and expectations relevant to clinicians and researchers, on the one hand, and patients and human subjects on the other, warrant attention by those who occupy either set of roles."

Johnston: "I have no doubt that comparative effectiveness research is needed and that it is most meaningful when conducted in real-world settings -- and that the realities of these real-world settings mean that getting informed consent is sometimes difficult or prohibitively time consuming.

"[But] the implications of wavering from existing informed consent requirements are profound and could have dramatic implications for public trust in medicine. These implications must be thoroughly debated and weighed against the value of the research."

Koski: "Informed consent is more than going through the motions to get a signature on a form to satisfy a regulatory requirement. If research has been performed in accord with an appropriately authorized waiver of consent, consent may be sought for continued participation, but what has been done has been done."

Friday Feedback is a feature that presents a sampling of opinions solicited by MedPage Today in response to a healthcare issue, clinical controversy, or new finding reported that week. We always welcome new, thoughtful voices. If you'd like to participate in a Friday Feedback issue, reach out to e.chu@medpagetoday.com or @elbertchu.

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